Senior Director – Drug Substance Validation and Tech Transfer

Senior Director – Drug Substance Validation and Tech Transfer

Requirements

• Bachelor’s degree in engineering or a related field with 15+ years of relevant experience (graduate degree preferred)
• Proficiency in drug substance manufacturing, including cell culture, media/raw materials, downstream purification, and process analytical technologies
• Experience in fermentation, continuous manufacturing, and conjugation is a plus
• Engineering of packaging and shipping solutions for biologics drug substance
• Strong understanding of qualification and packaging life-cycle activities, including compliance with global regulatory requirements and GDP standards
• Demonstrated ability to lead diverse, cross-functional teams and inspire innovation in a global, matrixed environment
• Exceptional interpersonal skills with the capacity to influence, collaborate, and build consensus across multi-disciplinary teams

Responsibilities

• Lead, mentor, and manage a team of 6–8 subject-matter experts responsible for overseeing commercial drug substance tech transfer projects across internal and external sites within the global AstraZeneca network
• Drive shipping qualification activities for biologics drug substance (DS) and drug product (DP) to establish robust global supply chains
• Cultivate a culture of continuous improvement by identifying and translating opportunities into actionable plans
• Lead initiatives to enhance operational efficiency using lean methodologies and risk-based approaches
• Collaborate across technical, quality, and leadership teams to deliver innovative strategies and drive digital transformation
• Develop and implement a vision for sustainable packaging engineering and shipping qualification practices
• Provide leadership across multi-disciplinary teams to establish and implement global best practices, guidelines, and training for tech transfer and validation processes
• Champion modernization by authoring and updating procedures and guidelines to reflect state-of-the-art approaches
• Streamline processes using lean, risk-based methodologies and establish priorities for Business Process Management

Preferred Qualifications

• Advanced degree (PhD strongly preferred)
• Experience with emerging modalities (e.g., ADCs, radioconjugates, cell therapies)
• Familiarity with digital transformation tools (e.g., process modeling, product lifecycle management, data visualization)
• Certification or experience in Project/Portfolio Management, Lean, or Six Sigma methodologies
• Expertise in temperature-controlled transport, packaging, and monitoring solutions